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City Dallas / / Company Unique Pharmaceutical Ltd / SS Unique Pharmaceutical Ltd / / Facility JNTRY TYl'e ESTASUSHMENT INSPECTED Temple / iMENT INSPECTEO Temple / B Complex / North Central Expressway / 1NSP£CTEO Temple / / / IndustryTerm rubber stoppers / contamination ofthe drug product / release ofdrug product / deficient regarding systems / drug product / human drug products / aseptic manipulation ofdrug products / aseptic processing areas / media fills / rubber vial stoppexs / closure systems / aseptic processing / pharmacy technicians processing drug products / steel trays / proces.-;ing ofdrug products / human drug product / drug products / aseptic processing area / / Organization PAGES DEPARTMENT OF HEAI / FDA / DEPARTMENT OF HEALTH AND HUMAN SERVICES / / Person Scott T Ballard / Darla J. Christopher / Daniel Volney / Danie / Ste / Darla J. Chri / FEI NUM BI / / / Position Investigator / portion ofthe technician / Chief Executive / Chief Executive Officer / General / technician / Officer / Director / same technician / representative / pharmacy technician / Director ofQuality / Chief / / Product Glycopyrrolate / Promethazine / fS / Sodium Bicarbonate / Dextrose / Oxytocin / Bacitracin / Calcium Chloride / Lidocaine / Lansoprazole / Nystatin / Dexamethasone Acetate / Tnt / Ondansetron / / ProvinceOrState Texas / PAGES DEPARTMENT OFHEALm AND HUMAN SERVICES FOOD AND DRUO ADMINJSTRATION DiSTRICT / DEPARTME.t'IT OF HEALTH AND RUMAN SERVICES FOOD AND DRUG AOMINISTRATION DISTRICT / / RadioStation WHOM / / Technology artificial intelligence / / URL www.fda / www.fda.gov/oc/industry / / SocialTag